Ispire’s IKE Tech Presents Biometric Age-Gating to FDA, Demonstrates 100% Block Rate
Ispire’s joint venture IKE Tech presented its AI-powered compliance platform, featuring biometric age-gating, blockchain-based authentication and AI governance, to FDA’s Center for Tobacco Products. The company’s standalone blockchain age-gating PMTA, accepted June 2025, demonstrated 100% underage activation prevention and 91% adult usability.
1. Joint Venture FDA Presentation
IKE Tech, a joint venture of Ispire Technology, Berify and Chemular, engaged directly with the FDA’s Center for Tobacco Products to present its AI-powered compliance infrastructure. The session focused on biometric point-of-use age verification, blockchain-based product authentication and AI-driven governance to tackle underage ENDS access and illicit supply.
2. PMTA Acceptance and Human Factors Study
IKE Tech’s standalone component PMTA for its interoperable blockchain age-gating technology was accepted by FDA in June 2025. A multi-center human factors validation study demonstrated 100% prevention of underage device activation and 91% adult usability ratings.
3. Regulatory Framework Proposal and Outlook
IKE Tech argued that software governing tobacco products should be regulated under the Tobacco Control Act, urging FDA to adapt its PMTA framework for dynamic software. FDA’s March 2026 draft guidance on flavored ENDS referenced device access restrictions, underlining potential alignment with IKE Tech’s proposed approach.